Principal Scientist

Job Description

Summary of Key Responsibilities:

Responsible for managing and running Method development, validation, and qualification projects for plate based ELISAs and quantitative PCR

Lead the development, optimization, and qualification of impurity ELISAs.

Have strong understanding of ICH guidelines regarding host cell proteins(HCPs).

Support and manage external CRO studies by reviewing validation and qualification data, methods, and reports.

Independently analyze, compile, and present data in oral presentations to cross functional teams.

Write and review SOPs, analytical test methods, protocols, and reports.

Author and review Development reports, qualification reports, test methods, SOPs, etc.

Mentor junior staff and oversee laboratory activities including but not limited to equipment maintenance and managing critical reagent inventory.